BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVAGINAL MESH

    MDR report key: 2941285 · Received January 27, 2013

    Report

    Report Number
    MW5028789
    Event Type
    Injury
    Date Received
    January 27, 2013
    Date of Event
    June 2, 2010
    Report Date
    January 27, 2013
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD MESH IMPLANTED FOR A PROLAPSED UTERUS. I ALSO HAD A BLADDER SLING PLACED. IN (B)(6) 2011, I WAS EXAMINED, AND FOUND TO HAVE THE SAME ISSUES AS BEFORE. THIS TIME I HAD A RECTOCELE AS WELL AS A CYSTOCELE. DATES OF USE: (B)(6) 2010 - (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36564 TRANSVAGINAL MESH MESH FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization